FDADecember 10, 2015device

Flow-i Anesthesia System Product Usage: The indication for the Flow-i Anesthesia System is administering inhalation anesthesia while controlling the entire ventilation of patients with no ability to breath, as well as in supporting patients with a limited ability to breath. The system is intended...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Electrical issues in the control, monitoring or panel sub-systems, caused by the printed circuit boards (PCBs) that control the sub-systems. The problems manifested as multiple re-starts of the sub-systems and, in a few instances, disabling of the system has occurred. Replacement PCBs are now available to correct the issues. Only the Model C20 is affected in the US.

What to do

FDA enforcement status: Terminated

Brands named

maquet cardiovascular us salesmaquetmaquet cardiovascular

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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